Pregnancy is often a risky time for women, but in the U.S., a woman's pregnancy can present even more complications depending on where she lives. Recently, the March of Dimes classified more than 35% of U.S. counties as "maternity care deserts", with little or no access to pre or postnatal care. With nearly two out of three deaths occurring in the postpartum period, particularly through heart conditions, infection, hemorrhage, high blood pressure, or stroke, the lack of access for women in the year after birth can be critical.
To address the health issues that often come with maternal healthcare deserts, the National Institute of Health's (NIH) Rapid Acceleration of Diagnostics Technology (RADx) program launched the Maternal Health Challenge – a competition to develop new medical devices women can use at home or in clinics to help detect, diagnose, and monitor diseases in the first year after birth. The technologies, such as non-invasive wearables, were explicitly designed to function outside of large hospital settings. Together, the devices could be a precious resource for women that don't have ready access to postpartum healthcare.
Prof. Suchitra Chandrasekaran
"I think we're at a real turning point in medicine, especially in maternal health where the marriage of technology and evidence-based medicine has to happen, whether we are ready for it or not," says Suchitra Chandrasekaran, lead investigator on the study and associate professor of obstetrics and gynecology in the Emory School of Medicine. "One thing this challenge did was really push us over the edge to embrace that and get ready for it. We saw how the technology could be critically important for overall maternal health care with the potential to decrease maternal morbidity and mortality."
For the competition, the NIH evaluated more than 80 initial submissions for feasibility before sending devices from 10 finalists to Emory University's obstetrics and gynecology clinics for testing in patient subject studies.
"All of the biotech companies that participated in the challenge were very impressive," says Morgan Greenleaf, associate dean of Innovation in Emory School of Medicine, who was involved in the challenge. "I expect to see great success for many of them, like the smartphone app that estimates hemoglobin levels based on an image of a user's nail beds, enabling physicians to track the data in a non-invasive way. It's this type of biomedical device that enables better clinical decision making by gathering data remotely where hospital access is limited."
Chandrasekaran led the team that evaluated the devices competing for the NIH award. They were able to recruit a cohort of 63 mothers by impressing upon them the importance of these technologies and how they could help them postpartum, as well as contribute to the future of maternal health care.
"With maternal health care deserts, an MD might be absent, but there are non-physician providers or midwives who are taking care of women," says Chandrasekaran. "The hope with these technologies is to enable any type of health care provider to triage a situation and determine if the patient needs to go to a hospital or if they can be treated on-site. That way, they can make data-informed decisions."
Emory's evaluation skills built on their experience with COVID-19 diagnostics
The Emory evaluation team's work benefited from their previous experience with an earlier RADx program, where they learned to develop diagnostic tests that could quickly identify variants in COVID-19.
"We took a lot of learnings from RADx and knew we'd be able to develop other types of diagnostics for different fields, like maternal health" says Greg Martin, the team's clinical principal investigator. "Fast forward to where we are today, trying to tackle one of the biggest challenges for our health care system, maternal health and peripartum complications, and our challenge winners will be able to make a real difference."
Chandrasekaran and Martin both believe they are on the verge of a new evidence-based approach to medical diagnosis, driven by a fortuitous combination of the pandemic and the RADx approach to developing new diagnostics.
Finalists in the competition included 10 companies that created wearables, patches, and diagnostics that could remotely measure blood pressure and cardiovascular health, as well as devices that monitored for postpartum bleeding, sepsis, urinary tract infections, anemia, and maternal depression and could alert clinicians remotely in case of problems.
The winners of the challenge, announced in October, were awarded more than million dollars each to further develop their technologies for clinical use.
